A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib

Sponsor

Exelixis (Industry)

Overall Status

Completed

CT.gov ID

NCT00570635

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

5.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the clinical benefit of the KIT inhibitor XL820 in subjects with advanced gastrointestinal stromal tumors (GIST) who are resistant to or intolerant of Imatinib and/or Sunitinib.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms	Drug: XL820 Drug: XL820	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Study of XL820 in Subjects With Advanced Gastrointestinal Stromal Tumors Resistant to or Intolerant of Imatinib and/or Sunitinib

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: XL820 XL820 capsules administered orally as a single agent at a dose of 800 mg daily
Experimental: B	Drug: XL820 XL820 capsules administered orally as a single agent at a dose of 300 mg twice daily

Arm

Intervention/Treatment

Experimental: A

Drug: XL820

XL820 capsules administered orally as a single agent at a dose of 800 mg daily

Experimental: B

Drug: XL820

XL820 capsules administered orally as a single agent at a dose of 300 mg twice daily

Outcome Measures

Primary Outcome Measures

Clinical benefit, defined as either confirmed complete response, confirmed partial response, or evidence of stable disease lasting ≥16 weeks, in subjects with advanced GIST resistant to/intolerant of imatinib and/or sunitinib [Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter]

Secondary Outcome Measures

Safety and tolerability of XL820 [Assessed at each visit]
Progression-free survival, duration of response, and overall survival [Assessed until progression]
Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST [Assessed during periodic visits]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with metastatic or locally advanced or unresectable GIST who have intolerance of or disease progression following prior treatment with imatinib and/or sunitinib
ECOG (Eastern Cooperative Oncology Group) performance status ≤2
Must have measurable disease per RECIST (Response Evaluation Criteria in Solid Tumors)
Recovery from toxicity from prior therapy to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 or to subject's baseline status
Adequate organ and marrow function
Sexually active subjects (male and female) must agree to use accepted methods of contraception during the course of the study and for 3 months following discontinuation of study drugs.
Female subjects of childbearing potential must have a negative pregnancy test at enrollment.

Exclusion Criteria:

Therapy with imatinib or sunitinib within 14 days before the first dose of study drug
Chemotherapy, immunotherapy, targeted therapy, chemoembolization, or any investigational drug for the treatment of GIST after the last dose of imatinib or sunitinib
Anticoagulation with warfarin or coumarin-related compounds
Radiation to ≥25% of bone marrow within 28 days of study entry
Treatment with other investigational agents within 28 days of the first dose of XL820
Known central nervous systems metastases
Uncontrolled or intercurrent illness
Pregnancy or breast-feeding
Active bacterial or viral infection requiring systemic treatment

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Los Angeles	California	United States	90095
2	Park Ridge	Illinois	United States	60068
3	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Exelixis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Exelixis

ClinicalTrials.gov Identifier:

NCT00570635

Other Study ID Numbers:

XL820-201

First Posted:

Dec 11, 2007

Last Update Posted:

Jun 7, 2013

Last Verified:

May 1, 2013

Keywords provided by Exelixis

GIST

Gastrointestinal Cancer

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors

Gastrointestinal Neoplasms

Digestive System Neoplasms

Study Results

No Results Posted as of Jun 7, 2013